Impact of CD34+ Cell Dose on Progression-free Survival Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/29/2018
Start Date:October 2015
End Date:October 2019
Contact:Craig Sauter, MD
Phone:212-639-3460

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A Multi-center Randomized Phase II Study of the Impact of CD34+ Cell Dose on Progression-free Survival Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)

The purpose of this study is to study the impact of stem cell dose on outcome after
autologous transplant.

Following enrollment, patients will be CD34+ stem cell mobilized at the discretion of the
treating attending physician with the plerixafor for the achievement of >6 x10^6 CD34+
cells/kg. The patients that fail to mobilize >6 x10^6 CD34+ cells/kg will not be randomized
and will subsequently be followed for disease progression and overall survival.. Patients
with >6 x10^6 CD34+ cells/kg cryopreserved on study will be admitted to the hospital for
planned ASCT. Patients will be randomly infused with either 3-4 x 10^6 CD34+ stem cells/kg or
6-8 x10^6 CD34+ stem cells/kg on d0 per study randomization. The cell dose ranges within the
two groups allows variability within aliquots of cells at the time of cryopreservation.
Patients will receive standard supportive measures (including: growth factor support
post-HDT/ASCT, antimicrobial prophylaxis, red blood cell and platelet transfusion and
treatment for neutropenic fever) as per institutional guideline practices.

Inclusion Criteria:

- Age ≥ 18 years old

- Diagnosed with relapsed or refractory de novo DLBCL or follicular lymphoma transformed
to DLBCL to one previous line of anthracycline-containing chemotherapy

- KPS ≥ 70

- Complete or partial response by IWG Working Group or ICML Criteria to maximum of one
salvage line of chemotherapy without pre-HDT/ASCT salvage radiotherapy.

- Eligible for high-dose therapy and autologous stem-cell rescue

- Serum creatinine ≤ 1.5 mg/dL, or if creatinine >1.5 mg/dL, calculated creatinine
clearance of ≥50 mL/min by 24 hour creatinine clearance or CKD-EPI.

- Last cycle of most recent salvage therapy within 8 weeks of enrollment

- Total bilirubin < 2.0 mg/dL

o If Gilbert‟s disease is suspected and total bilirubin > 2.0 mg/dL, direct bilirubin
must be < 2.0 mg/dL

- Females of childbearing potential and males must agree to use an acceptable form of
contraception per institutional practices.

Exclusion Criteria:

- Disease progression by IWG Working Group or ICML Criteria since last therapy

- Prior autologous or allogeneic stem cell transplantation

- HIV infection

- Comorbid condition(s) which, in the opinion of the attending physician and/or MSKCC
Principal Investigator, will preclude stem cell mobilization and/or high-dose therapy
with autologous stem cell rescue

- Treatment plan that includes post-transplant maintenance therapy

- Salvage therapy that includes involved field radiotherapy
We found this trial at
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Manhasset, New York 11030
Phone: 516-734-8973
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Phone: 212-305-5098
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Michael Becker, MD
Phone: 585-275-5823
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
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Cleveland, Ohio 44106
Phone: 216-844-3951
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Commack, New York 11725
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500 Westchester Avenue
Harrison, New York 10604
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Middletown, New Jersey 07748
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Phone: 414-955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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225 Summit Avenue
Montvale, New Jersey 07645
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Phone: 615-342-7440
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Craig Sauter, MD
Phone: 212-639-3460
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Matthew Lunning, D.O.
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Rockville Centre, New York 11570
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San Antonio, Texas 78229
Principal Investigator: Paul Shaughnessy, MD
Phone: 210-575-3817
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